Label: RITE AID MAXIMUM TOOTHACHE RELIEVER- benzocaine, menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 16, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzocaine 20%

    Menthol 0.26%

  • PURPOSE

    Purpose

    Oral Pain Reliever

    Oral Pain Reliever

  • INDICATIONS & USAGE

    Use

    • for the temporary relief of pain due to toothaches
    • to help protect against infection of minor oral irritation
  • WARNINGS

    Warnings

    Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

    • pale, gray, or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

    Do not use

    • more than directed
    • for more than 7 days unless told to do so by a dentist or doctor
    • for teething
    • in children under 2 years of age

    Stop use and ask a doctor if

    • swelling, rash or fever develops
    • irritation, pain or redness persists or worsens
    • symptoms do not improve in 7 days
    • allergic reaction occurs

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • cut open tip of tube on score mark
    • do not use if tip is cut prior to opening
    • adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product
    • children under 2 years of age: do not use
  • OTHER SAFETY INFORMATION

    Other information

    • do not use if tip is cut prior to opening
    • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
    • do not use continuously
    • this formula will stay in place for extended duration of relief
    • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
  • INACTIVE INGREDIENT

    Inactive ingredientsAmmonium Glycyrrhizate, Flavor, Polyethylene Glycol, Sodium Saccharin, Sorbic Acid

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    RITE AID

    30 HUNTER LANE

    CAMP HILL, PA 17011

    TAMPER EVIDENT: Do not use if tube tip is cut prior to use

  • PRINCIPAL DISPLAY PANEL

    RITE AID® PHARMACY

    MAXIMUM toothache reliever

    immediate relief of toothache pain

    Fast acting GEL

    ORAL PAIN RELIEVER

    Double Medicated

    • 20% Benzocaine for toothache pain relief
    • Menthol to sooth gums

    NET WT 0.42 OZ (12 g)

    RA MaxStr Toothache Rel Gel 2821385R1

  • INGREDIENTS AND APPEARANCE
    RITE AID  MAXIMUM TOOTHACHE RELIEVER
    benzocaine, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.26 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-6036-91 in 1 CARTON03/04/2019
    112 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/04/201904/22/2022
    Labeler - Rite Aid (014578892)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(11822-6036)